NCT03355235 - Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant | Crick | Crick

Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

N/ACompletedNCT03355235

Wake Forest University Health Sciences50 enrolled

Overview

The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.

The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.

Study Type

OBSERVATIONAL

Enrollment

50

Conditions

Stem Cell Transplant Complications

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with multiple myeloma * Patients who will undergo pre-transplant evaluation with intentions to proceed to autologous stem cell transplant after stem cell collection. * Patients willing and able to understand and sign an informed consent form * Patients 18 yrs of age or older Exclusion Criteria: * Patients with unstable psychiatric illness within the past 3 months of study enrollment. * Patients who are considered unable to perform study evaluations at the investigator's discretion. * Patients who are unable to read. (If patients require reading glasses, they must be worn at time of test.) * Patients who do not proceed to stem cell transplant within 60 days of stem cell collection will be excluded from study. * Patients who receive more than one cycle of chemotherapy between the time of stem cell collection and transplant will be excluded from study.

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Scores of the PROMIS Cognitive Function, short form 8a

Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function, short form 8a. The mean scores (and standard deviations) for each time points will be presented.

Time frame: Before to approximately 100 days after transplant

Scores of the Self-Administered Gerocognitive Exam (SAGE)

Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean scores (and standard deviations) for each time points will be presented.

Time frame: Before to approximately 100 days after transplant

Scores of the Montreal Cognitive Assessment (MoCA)

Will be assessed by Montreal Cognitive Assessment (MoCA). The mean scores (and standard deviations) for each time points will be presented.

Time frame: Before to approximately 100 days after transplant

Changes in scores of the PROMIS Cognitive Function, short form 8a

Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function, short form 8a. The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred.

Time frame: Before to approximately 100 days after transplant

Changes in scores of the Self-Administered Gerocognitive Exam (SAGE)

Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred.

Time frame: Before to approximately 100 days after transplant

Changes in scores of the Montreal Cognitive Assessment (MoCA)

Will be assessed by Montreal Cognitive Assessment (MoCA). The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred.

Data from ClinicalTrials.gov

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